Overcoming Regulatory Aversion to Novel Methods of Evidence Generation
Author:
Affiliation:
1. Pfizer New York New York USA
2. Pfizer Collegeville Pennsylvania USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1711
Reference6 articles.
1. The Evolution of Federal Regulation of Human Drugs in the United States: An Historical Essay
2. Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation
3. Prescription Drug User Fee Act (PDUFA).VI: fiscal year 2018–2022. Accessed September 23 2019.
4. Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation
5. Blincyto™ (blinatumomab).Approval Letter and FDA Review Documents. Accessed September 23 2019.
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